FDA says unapproved 'designer vagina' treatments are unsafe

In a statement, FDA Commissioner Scott Gottlieb, MD, said the agency has recently become aware of a growing number of manufacturers marketing devices that claim to treat conditions and symptoms related to menopause, urinary incontinence and sexual function.

But in a statement released Monday, the FDA said it's identified numerous cases of vaginalburns or scarring tied to vaginal rejuvenation, as well as post-procedural pain during sexual intercourse or recurring or chronic pain.

In another such incident, a woman who used a device by Cynosure called "Mona Lisa Touch" said, "Two days after the procedure, I developed severe and debilitating bladder/urethral pain". They are: Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen. If the companies fail to respond, the FDA said, it will consider next steps, which might include "potential enforcement actions".

In a safety communication, the FDA told patients and doctors that laser and radiofrequency devices approved to treat abnormal tissue have been improperly promoted to address sexual discomfort and vaginal dryness. The devices have also not been FDA approved for use in treating sexual dysfunction, such as decreased sexual sensation or pain during intercourse or urination.

But, they highlighted the fact that it did not clear the devices for symptoms related to menopause, urinary incontinence or sexual function.

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During the procedure, the tissue is destroyed or reshaped. They FDA has noted that these treatments are sold to women who have been treated for breast cancer early and experience menopausal symptoms. "The deceptive marketing of a risky procedure with no proven benefit, including to women who've been treated for cancer, is egregious", he said.

"The deceptive marketing of a risky procedure with no proven benefit, including to women who've been treated for cancer, is egregious", Gottlieb said. The FDA disagrees. But even though the agency originally approved the devices for certain treatments, it is legal for doctors to use them for off-label conditions. But these reports indicate these procedures can cause serious harm.

Women who've experienced adverse side effects tied to vaginal rejuvenation devices are encouraged to report their problem to MedWatch, the FDA's adverse-event-reporting program, the agency said.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.